This contract will provide NIAID with a broad and flexible range of nontraditional, proactive and developmentally-oriented capabilities to provide preclinical development support for promising products when such products emerge from investigator-initiated research studies. These capabilities will allow NIAID to more rapidly and efficiently close development and production gaps. Activities include but are not limited to small-scale production, preclinical testing and documentation leading to Investigational New Drug (IND) submission for Phase I, II, and III clinical testing. In particular this project will develop, produce, scale-up, characterize, formulate, vial and release Clinical Grade (cGMP) HIV-1 M Group Conserved Element DNAs for human Phase I clinical trials.